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Also known as JNJ-4804
JNJ-78934804 · 2 trials · 2 indications
Clinical remission is defined as an stool frequency (SF) subscore of 0 or 1, rectal bleeding (RB) subscore of 0, and an endoscopy subscore of 0 or 1.
Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score less than (\<) 150. CDAI scores range from 0 to approximately 600. Higher score indicates higher disease activity.
Endoscopic remission is defined as a Simple Endoscopic Score for Crohn's Disease (SES-CD) score of less than or equal to (\<=) 4 with at least a 2-point reduction from baseline and no subscore greater than (\>) 1 in any individual component. The SES-CD is based on the evaluation of 4 endoscopic components (presence/size of ulcers, proportion of mucosal surface covered by ulcers, proportion of mucosal surface affected by any lesions, and presence/type of narrowing/strictures) across 5 ileocolonic segments. SES-CD score can range from 0 to 56. Higher scores indicating more severe disease.
| Arm | Type | Description |
|---|---|---|
| JNJ-78934804 | EXPERIMENTAL | Participants will receive JNJ-78934804 induction dose at Weeks 0, 4, and 8 followed by JNJ-78934804 maintenance dose, once every 4 weeks (q4w) starting at Week 12. All participants who meet the rescue criteria will receive JNJ-78934804 induction dose at Weeks 16, 20, and 24 followed by JNJ-78934804 maintenance dose q4w starting at Week 28. Participants who complete double-blind treatment phase (Week 48) and who may benefit from continued study intervention in the opinion of the investigator will have the opportunity to enter the long-term extension (LTE) phase. |
| Guselkumab | ACTIVE_COMPARATOR | Participants with moderately to severely active UC will receive guselkumab induction dose at Weeks 0, 4, and 8 followed by guselkumab maintenance dose q4w starting at Week 12. All participants who meet the rescue criteria will receive JNJ-78934804 induction dose at Weeks 16, 20, and 24 followed by JNJ-78934804 maintenance dose q4w starting at Week 28. Participants who complete double-blind treatment phase (Week 48) and who may benefit from continued study intervention in the opinion of the investigator will have the opportunity to enter the long-term extension (LTE) phase. |
| Name | Type | Description |
|---|---|---|
| JNJ-78934804 | DRUG | JNJ-78934804 will be administered subcutaneously. |
| Guselkumab | DRUG | Guselkumab will be administered subcutaneously. |
Inclusion criteria: * Diagnosis of ulcerative colitis (UC) established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of UC. * Moderately to severely active UC defined as baseline (Week 0) modified Mayo score of 5 to 9, ...
JNJ-78934804 is an investigational small molecule being developed by Johnson & Johnson for inflammatory bowel disease. It is in Phase 3 clinical development for moderately to severely active ulcerative colitis and Crohn's disease. It has not been approved by the FDA and remains under clinical study.
JNJ-78934804 is being studied for the treatment of moderately to severely active ulcerative colitis and moderately to severely active Crohn's disease. Both are chronic inflammatory conditions of the gastrointestinal tract. The drug is investigational, so it is not yet available as a marketed treatment outside of clinical trials.
JNJ-78934804 is being developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The company is running the Phase 3 clinical program for the drug in ulcerative colitis and Crohn's disease.
JNJ-78934804 is in Phase 3 clinical development. Two Phase 3 trials are currently recruiting participants, one in moderately to severely active ulcerative colitis and one in moderately to severely active Crohn's disease. The drug is investigational and has not received FDA approval.
JNJ-78934804 is being evaluated in two recruiting Phase 3 trials. NCT07577856 is studying the drug in moderately to severely active ulcerative colitis with an enrollment of 644 participants. NCT07577843 is studying it in moderately to severely active Crohn's disease with an enrollment of 460 participants. Both are randomized, double-blind, and active-controlled.
The JNJ-78934804 Phase 3 trials enroll adults 18 years of age and older of any sex. Participants must have moderately to severely active ulcerative colitis or Crohn's disease. The studies are not open to healthy volunteers and are recruiting across sites in the United States, Europe, Asia, Latin America, and other regions.